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The I.H.S. Chips Power Standup Wheelchair helps promote mobility for its intended user, who typically is limited in full use of lower extremities. These limitations will usually be of long or permanent duration and caused by numerous medical conditions ranging from spinal cord injuries, broken bones, stroke, as well as numerous other disabilities.

The subject device, through a safe and effective lifting motion, helps promote well-being by enabling the user at will to safely and securely change his posture from a sitting position to fully upright, allowing the bodies natural articulation to accomplish this.

Standup Wheelchair. The main product components include a steel tubular welded frame which supports a sitting surface. Both the seat and the back support are made of a durable nylon material. In addition, the frame incorporates adjustable and removable armrests providing support for the user occupant and removable to facilitate transfer into and out of the wheelchair. Both leg rests and foot rests are designed in a unitized construction to structurally support the users body weight while standing. The foot rest assembly is designed to swing away to facilitate entry and exit to the Standup chair and the assembly is removable to facilitate transportation of the above described features are typical in predicate devices. Power is supplied to the device by incorporating two 12 volt wet or gel cell batteries providing a 24 volt system. This in turn supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors in turn provides power to a sealed gear box which transfers power to the rear wheels. The Penny & Giles PG 8 Programmable control system provides reliable, precise control and conforms to the latest International Standards.

This document is a 510(k) summary for a Standup Wheelchair. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document discusses:

• Description of Device: CHIPS Standup Wheelchair, including its components (steel frame, nylon seat/back, adjustable armrests, leg/foot rests, 2x12V batteries, 2 rear-mounted direct drive motors, Penny & Giles PG 8 Programmable control system).
• Intended Use: To promote mobility for users with limited lower extremity use, and enable users to change from a sitting to fully upright position safely.
• Predicate Devices: Levo (Mobil LCM) and I.D.C. (Lifestand).
• Technological Characteristics: Claims similarities to predicate devices and refers to "Section 4 - Technical Specifications and Test Reports," which is not provided in the given text.
• Nonclinical Tests: Mentions that nonclinical tests and their results support substantial equivalence and refers to "Section 4 - Technical Specifications and Test Reports."
• Standards/Approvals: States the Penny & Giles control system is manufactured to meet or exceed ISO 9001 and designed to ISO 7176/14, approved by TUV, and surpassed Swedish Handicap Institute Approval.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To answer your request, the document would need to include details such as:

1. Acceptance Criteria Table: Specific performance metrics (e.g., stability angles, braking distances, durability cycles, weight capacity) with numerical targets.
2. Study Details: Information about a formal study conducted to test these criteria, including:
   • Test protocols
   • Results against the criteria
   • Sample sizes (of devices, or simulated conditions)
   • Data provenance (e.g., lab testing, simulated environments)
   • Ground truth establishment (e.g., engineering standards, expert evaluation)
   • Adjudication methods (if applicable for subjective evaluations)
   • Information about human-in-the-loop or standalone performance (which is usually not relevant for a wheelchair's mechanical and electrical performance but might be for control interfaces).
   • Details on training sets, if any machine learning components were described (which they are not in this context).

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